Angiodynamics, Inc. is recalling 1,800 units of its IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kits. The product is being recalled because it was mislabeled with an incorrect fill volume, which could lead to improper use of the device during medical procedures. While no injuries or incidents have been reported, the error may affect how the balloon is prepared for treatment.
The incorrect fill volume printed on the label could lead healthcare providers to improperly inflate the device. This poses a risk of inadequate prostate immobilization during treatment or potential damage to the device, which could compromise the precision of medical procedures.
Recall Number: Z-1391-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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